Leaflet: information for the user

Etalpha2 micrograms/ml oral drops in solution

alfacalcidol

Read this leaflet carefully before you start taking this medicine, because it contains important information for you.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Etalpha is and what it is used for

2.What you need to know before starting to take Etalpha

3.How to take Etalpha

4.Possible side effects

5.Storage of Etalpha

6.Contents of the pack and additional information

Etalpha belongs to a group of medications called vitamin D analogs that regulate calcium and phosphorus levels in your body.

The active ingredient of Etalpha is alfacalcidol, a form of vitamin D.

Alfacalcidol exerts its action after being transformed into calcitriol (active form of vitamin D) in the liver.

The medication is indicated in situations where there is an alteration of calcium and phosphorus metabolism due to reduced production of 1,25-dihydroxyvitamin D.

Do not take Etalpha

• if you are allergic to alfacalcidol or any of the other components of this medication (listed in section 6).
• if you have high levels of calcium in your blood (hypercalcemia).

As Etalpha treatment may cause high levels of calcium in your blood (hypercalcemia), you should be aware of the following signs and symptoms of hypercalcemia:

-loss of appetite (anorexia)

-fatigue

-nausea

-vomiting

-constipation or diarrhea

-increased urine production

-sweating

-headache

-thirst

-high blood pressure

-drowsiness

-dizziness

Warnings and precautions

Consult your doctor or pharmacist before starting to take Etalpha.

Be especially careful with Etalpha if:

-you have arteriosclerosis, heart valve sclerosis, or kidney stones (nephrolithiasis). These conditions may worsen if you have high levels of calcium in your blood (hypercalcemia).

-you suffer from pulmonary calcification.

-you have kidney disease or any kidney impairment. To maintain an acceptable serum phosphate level, phosphate binders may be used.

-you have inflammatory diseases such as sarcoidosis. These conditions have the potential to increase your sensitivity to Etalpha.

-you are being treated with heart medications (cardiac glycosides). If your calcium levels in the blood increase too much (hypercalcemia), the use of these medications may cause changes in your heart rhythm.

Your doctor will perform blood tests during treatment to control your calcium and phosphate levels.

Use of Etalpha with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is essential to inform your doctor if:

• you are being treated with diuretics, preparations containing calcium, or other preparations containing vitamin D, as these may increase the risk of high levels of calcium in your blood (hypercalcemia).
• you are being treated with antiepileptic medications (barbiturates, phenytoin, carbamazepine, or primidone). You may need a higher dose of Etalpha.
• you are taking antacids containing magnesium, as these may increase the risk of high levels of magnesium in your blood (hypermagnesemia).
• you are being treated with preparations containing aluminum (such as aluminum hydroxide or sucralfate), as this may increase aluminum absorption.

-you are taking bile acid binders such as cholestyramine at the same time as Etalpha, as this may alter the intestinal absorption of Etalpha. To minimize the possibility of interference, alfacalcidol should be administered at least 1 hour before or 4-6 hours after the ingestion of bile acid binders.

Pregnancy and lactation

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Etalpha may be used during pregnancy and lactation only when your doctor considers it essential.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

The influence of Etalpha on your ability to drive and operate machinery is negligible or insignificant.

However, dizziness may occur during treatment, which you should be aware of if you drive or operate machinery.

Etalpha contains ethanol, sorbitol, macrogolglycerol hydroxystearate, and methyl parahydroxybenzoate

This medication contains up to 113 mg of alcohol (ethanol) per dose (corresponding to 2 micrograms of alfacalcidol), which is equivalent to 14% ethanol (alcohol). The amount in each dose of this medication is equivalent to less than 3 ml of beer or 1.5 ml of wine.

The small amount of alcohol in this medication does not produce any perceptible effect.

This medication contains 452 mg of sorbitol per ml, equivalent to 6.5 mg sorbitol/kg/day for an adult (70 kg). Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

This medication may cause stomach discomfort and diarrhea because it contains macrogolglycerol hydroxystearate.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

This medication contains less than 23 mg of sodium (1 mmol) per ml; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

1 ml or 20 drops of Etalpha oral drops in solution are equivalent to 2 micrograms of alfacalcidol (1 drop is equivalent to 0.1 microgram of alfacalcidol).

Adults and children over 20 kg of weight:

The initial dose is 1 microgram (0.5 ml) per day, that is, 10 drops per day.

Children under 20 kg of weight:

The initial dose is 0.05 micrograms per kg of weight per day.

The maintenance dose is generally between 0.25 and 1 microgram per day.

Your doctor may adjust these doses according to your needs. To do this, your doctor will perform blood tests or may request other diagnostic tests.

If you take more Etalpha than you should

If you have taken too much Etalpha, contact your doctor or pharmacist.

A overdose may lead to a high amount of calcium in your blood and urine. Therefore, your doctor may need to perform the necessary tests.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Etalpha

Do not take a double dose to compensate for the missed doses. Continue according to the prescribed dosage.

If you interrupt the treatment with Etalpha

Your doctor will indicate the duration of your treatment with Etalpha. Do not suspend the treatment beforehand, as it may be harmful to your health.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects (may affect up to 1 in 10 patients):

-High levels of calcium in the blood

-Excessive levels of phosphorus in the blood

-Abdominal pain and discomfort

-Dermatological eruption

-Itching

-Excessive calcium in the urine

Less Frequent Adverse Effects (may affect up to 1 in 100 patients):

-Confusion

-Headache

-Diarrhea

-Vomiting

-Constipation

-Nausea

-Muscle pain

-Worsening of renal function (including acute renal insufficiency)

-Kidney stones

-Calcium deposits in the kidneys

-Fatigue

-Weakness

-Discomfort

-Calcium deposits in non-osseous tissues

Rare Adverse Effects (may affect up to 1 in 1000 patients):

-Dizziness

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store in refrigerator (between 2°C and 8°C).

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Etalpha

-The active ingredient is alfacalcidol.

One milliliter of solution (20 drops) contains 2 micrograms of alfacalcidol.

-The other components are sorbitol (E-420), ethanol, macrogolglycerol hydroxystearate, sodium citrate, methyl parahydroxybenzoate (E-218), citric acid monohydrate, all-rac-α-tocopherol, and purified water.

Appearance of the product and contents of the packaging

Colorless, transparent, or slightly opalescent solution.

Etalpha oral drops in solution are presented in an amber glass bottle of 10 ml with a dosing dropper.

Holder of the marketing authorization

CHEPLAPHARM Arzneimittel GmbH

Ziegelhof 24

17489 Greifswald

Germany

Local representative

Laboratorios Rubió, S.A.

Industria, 29 – Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Responsible for manufacturing

LEO Pharma A/S

Industriparken 55

DK-2750 Ballerup

Denmark

Last review date of this leaflet: January 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.